ClearanceBrief
Recall Z-0744-2007 ยท JIX Calibrator, Multi-Analyte Mixture

Mega Diagnostics

Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials.

DateApr 14, 2007 (initiated Sep 20, 2006)
StatusTerminated
ReasonPotential for microorganism growth in the alcohol standard.
Root causeOther
ActionThe firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product
Quantity6 units
DistributionCountry of Indonesia
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K882117ETHYL ALCOHOL STANDARD
Verichem Laboratories, Inc., Aug 4, 1988